Speaker Notes

DISPLAY SLIDE # 1

Welcome participants.

STATE:For the next 10 minutes we’ll be talking about improving patient safety in our hospital. As you may know, our hospital is involved in a project called MedSun, which is a device-reporting project with the FDA. MedSun involves many other hospitals that are working with FDA to ensure patient safety by reporting adverse events involving medical devices.

Reporting Problems with Medical Devices

At the end of this session you will be able to:

Identify several types of medical devices

Explain why reporting problems with medical devices is important

Describe your role in promoting patient safety with medical devices

Describe the steps to take to report an adverse event or problem with a medical device in our hospital

Speaker Notes

DISPLAY SLIDE # 2

STATE:Our goal for the session is to

increase awareness of incidents that potentially involve a medical device or technology and

encourage our staff to report it quickly.

READ OBJECTIVES ON SLIDE:

At the end of the session you will be able to:

Identify several types of medical devices

Explain why reporting problems with medical devices is important

Describe your role in promoting patient safety with medical devices

Describe the steps to take to report an adverse event or problem with a medical device in our hospital

Speaker Notes

DISPLAY SLIDE # 3

EXPLAIN:This slide lists types of medical devices in some general categories that you may be familiar with or work with on a daily basis. Some devices you may not realize are considered medical devices by the FDA such as laboratory solutions or computer software. This list is not all-inclusive but gives you some idea of the spectrum of devices. As you may know, devices can be anything from a q-tip and tongue depressor to a sophisticated scanner or hi tech heart lung machine. It’s important to note here that regardless of how the simple the device may be, it can still be problematic and contribute to an adverse event for a patient.

“Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single individuals.”

Speaker Notes

DISPLAY SLIDE # 4

STATE:This next slide is a quote from Dr. Lucien Leape from Harvard that reads, “ Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of a single individual.” This quote addresses the complexity of a medical error and the challenges of determining what happened, who’s involved and why. The kinds of adverse events we’re discussing with devices falls under the general category of medical error.

Speaker Notes

DISPLAY SLIDE # 5

This slide is a modified version of the “Swiss Cheese” model developed by James Reason, a well-known safety expert. It depicts a trajectory of harm (shown here as the black arrow) that moves through a hole or breaks-downs in systems where the cumulative effects of failures result in harm to a patient. Also, it can be described as a domino effect that continues because no intervention occurs. It’s important to note here that in isolation, each hole or failure in and of itself may be okay but as a process of successive failures the result can be serious harm or even death for a patient.

Let’s look at the model in the context of a problem involving an infusion pump. We begin with an infusion pump that’s not maintained and prone to break-down – a free flow event happens. The problem is not reported completely or in detail for the biomedical department, the tag only says, “broken, “ the hospital’s culture is one in which staff expect that device problems will always exist and nothing gets fixed well anyway, nor are they even communicated among departments, so free flow happens again and the result is catastrophic. You can apply this model to any potential for harm from a device that can easily slip through the holes.

Think About the Device and its Environment

Environment

Electric Power, Heat, Humidity,

Light, Other Devices (EMI)

Staff

Accessories & Disposables

Exhalation Filter

Heated Humidifier

Medication Port & Filter

Pressure Valves

Tracheal Tube

Speaker Notes

DISPLAY SLIDE # 6

EXPLAIN:

We know of the interface between devices and patients, but it’s important to consider the device in its many interfaces as well. The device shown here is a ventilator. When an adverse event occurs, it’s important to consider all characteristics of the

Environment: such as the power source, lighting, and other devices, and the

People involved: who may be the patient, device-operator, or visitors, and any

Accessories and disposables: attached such as filters, valves, ports, and tubing, etc.

Any or many of these aspects of the adverse event may be the reason or a contributing factor and warrants further investigation to determine what may have happened.

What Types of Medical Device Problems Should I Look for?

Instructions/labeling/packaging

Defects

Software problems

Failure to work as intended/malfunction

Interactions with other devices

Use errors

Combinations of the above

Speaker Notes

DISPLAY SLIDE # 7

STATE:

This is a list of broad categories or ways to classify possible causes of adverse events. Some of what is listed here may remind you of problems you’ve had or times you have questioned a device as the reason for a problem.

Let’s briefly run through the list here and we’ll cover more detail with examples in the next several slides from actual MedSun reports.

Speaker Notes

DISPLAY SLIDE # 8

NOTE to instructor: Briefly describe the examples on each slide. It’s important to maintain a steady pace as you move through these next few slides to keep within the time frame. Spend approximately 1 minute per slide.

Instructions/Labeling/Packaging

age or weight specific usage information is not provided in the instructions

new cardiac cath kit outer package was changed to non-sterile but staff weren’t aware and assumed it was all sterile

taping devices together, or substituting parts because of problems with a certain part

“Out-of-the-box” problems that are identified before use on a patient

ECMO membrane found to leak prior to being used on patient

Speaker Notes

DISPLAY SLIDE # 16

STATE: Next, let’s look closely at . . .

“What Do We Mean by “Potential for Harm?”

Events that are caught before anything harmful occurred

Important observations of a chronic problem with a device

Problems which lead staff to develop “work-a-rounds”

“Out-of-the-box” problems that are identified before used on a patient

What Do I Report?

If there was an injury, what happened to the persons affected?

second degree burn, respiratory arrest

What, if any, were the problems with the device(s) involved?

circumcision clamp failed due to mismatched parts

What, if any, were the original medical procedures for which the devices were used?

What, if any, were the follow-up medical procedures required because of the event?

repeat surgery, antibiotics administered

What are the names of the manufacturers of the devices involved?

What are the relevant manufacturer device identification numbers?

serial, model, lot, catalog, and any other specific information

What did you do to solve the problem?

Speaker Notes

DISPLAY SLIDE # 17

STATE: We’ve looked at when to report, let’s focus now on what to report. This information is so valuable because it’s focused on getting complete information initially and possibly from the staff person who may have been directly involved. Then the effort is made to have a complete report and it’s expedites any follow up steps.

Speaker Notes

DISPLAY SLIDE # 20

STATE: We’ve listedSome Issues We’ve Addressed here at Our Hospital

With device problems and the actions we took to solve them. We hope this will reinforce with everyone the importance of reporting what you’ve seen so we can intervene and prevent any harm to patients, staff, and visitors to our hospital.

READ SLIDE

What Was Reported. . .

What We Did. . .

Fostering a Climate of Patient Safety

(Customized responses would be listed below)

Feedback and communication

Learning from errors

Compliance with policies and procedures

Teamwork

Speaker Notes

DISPLAY SLIDE # 21

STATE: Here’s what we need to do as an organization to

“Foster a Climate of Patient Safety”

STATE: We need to

Provide feedback and communication about adverse events and close calls

Learn from our errors

Comply with our policies and procedures

And promote and exhibit teamwork

If You’re Not Sure What or How to Report

(Customized responses would be listed below)

Refer to the incident reporting section in our Policy and Procedures manual